Visual, functional, material, and dimensional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.The everest surgical technique was reviewed and the following relevant information was identified: it is the responsibility of the physician to adequately instruct the patient that postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.The root cause could not be determined conclusively.It could not be determined if the set screws were placed with sufficient torque or if the rods were fully reduced.This may have led to sub-optimal engagement between the set screw and the rod, which may have contributed to loosening and eventually disengagement.Patient compliance may have also played a factor, the patient was reportedly lifting heavy objects after the procedure.
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